MAUDE Adverse Event Report: ATRIUM MEDICAL C-QUR MESH MESH, SURGICAL, POLYMERIC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Obstruction/Occlusion (2422); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product number, lot number or sample was provided. Per the article adhesion characteristics of mesh placed intra peritoneally and adhesiolysis related complications during laparoscopic re-exploration after ventral hernia repair are associated with unique properties of the mesh and/or barrier. (b)(4).

Event Description

Received an article titled "prospective evaluation of adhesion characteristics to intra-peritoneal mesh and adhesiolysis related complications during laparoscopic re-exploration after prior ventral hernia repair". The article characterized the adhesion characteristics of absorbable and non-absorbable barrier coated meshes and to report adhesiolysis related complications during laparoscopic re-exploration after prior ventral hernia repair. Per the article adverse events included adhesions, infection, recurrence, small bowel obstruction, pain, incarceration and small bowel enterotomy.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7455763
• MDR Text Key: 106343454
• Report Number: 3011175548-2018-00389
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/24/2018 Patient Sequence Number: 1